Dieters may remember the scandal around the “fen-phen” diet drug in the late 1990s. As a pharmaceutical liability lawyer, I certainly do, since it resulted in a very large settlement. The “fen” part of the drug combination was fenfluramine or dexfenfluramine, which changed the brain’s release of serotonin in a way that reduced appetite. Unfortunately, it also was shown to damage the heart valve in a large minority of users, leading to serious chronic heart and lung problems. The late-1990s settlement of multidistrict litigation on fen-phen permitted lawsuits to go forward if they allege they developed a certain level of primary arterial hypertension (PPH). Carmen Cauthen’s lawsuit claimed she had PPH, but the district court and the Third U.S. Circuit Court of Appeals agreed in In re Diet Drugs Product Liability Litigation that she didn’t meet requirements.
The diet drugs were marketed by a predecessor in interest to the drug company Wyeth, which agreed to a nationwide settlement with users in 1999. That settlement barred class members from suing over fen-phen injuries except in certain circumstances. One exception was for people who developed PPH from using the drugs, and can show, among other things, that a different condition was ruled out with tests showing lung capacity was greater than 60% of predicted at rest.
Carmen and Ricky Cauthen sued in 2011 in Philadelphia state court, relying on a cardiologist’s report saying Carmen Cauthen’s lung capacity was at 56%. Wyeth notified them that they were prohibited from suing because they didn’t meet the 60% cutoff. After they didn’t drop the case, Wyeth moved in federal court for an injunction against the lawsuit, saying it violated the settlement. In opposition, the Cauthens filed a declaration from their cardiologist, arguing that the predicted capacity to which Carmen was compared was arbitrary, and that the difference between 56% and 60% is clinically irrelevant. The district court enjoined the suit anyway.
On appeal, the Cauthens argued that the district court should have given more weight to the cardiologist’s declaration that Carmen has PPH, and that the settlement’s standard has been made obsolete by advances in diagnostic capabilities. The Third Circuit was not impressed; it upheld the settlement as “clearly and unambiguously” requiring a finding of greater than 60%. The settlement requires the number, not a diagnosis of PPH caused by diet drugs or a diagnosis excluding “greater than mild lung disease.” It also rejected the argument that the settlement should be re-formed to account for advances in diagnosis, noting that it was not raised in the district court and is therefore waived.
As a dangerous drug attorney, I would have preferred to see a more detailed examination of this couple’s claims. The cardiologist’s statement seems to be saying that the 60% cutoff is arbitrary, particularly since the baseline it’s compared to is nothing more than the average lung capacity of people who match the patient’s height, weight, gender and race. Any measurement would be somewhat arbitrary, of course, which is why a doctor’s diagnosis might be a better standard to use in settlements like these. I also sympathize with the argument that diagnostic technology has improved over the last 14 years. As a defective drug lawyer, I believe the interests underlying the settlement—to compensate people with permanent disabilities from taking fen-phen—would be better served with a reexamination of the settlement.
If you believe you were seriously injured, sickened or lost a family member because of a drug that was too dangerous to prescribe, Carey, Danis & Lowe can help. For a free, confidential consultation, send us an email or call toll-free at 1-877-678-3400.
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